Title: Informed consent procedures

CONTENTS

1.Purpose

2.Responsibilities

3.Procedure:

a)Informed consent documents

b)Obtaining informed consent

c)Storage of informed consent documents

d)Verification of informed consent

1. PURPOSE

1.1The purpose of this Standard Operating Procedure is to describe the
process to be followed when obtaining written obtained consent from trial subjects.
It also describes the distribution and storage of the consent forms.

1.2These processes form the minimum standards to be followed in order to
comply with ICH-GCP guidelines.

2.
RESPONSIBILITIES

††††† It is
the responsibility of the investigator to obtain written informed consent††††

††††† from
all trial subjects before the conduct†
any trial related procedure.

3. PROCEDURE

3.1 Informed
consent documents.

The informed consent documents include any written
information to be provided to the trial subject i.e. the informed consent form,
patient information sheet, additional advice leaflets etc.

The
investigator must ensure that the appropriate ethics committee approves the
documents prior to use and that the approval documentation contains reference
to the correct version of the informed consent documents.

If during the
course of a study any new information becomes available that may be relevant to
the subjects consent the documents should be revised. The revised version
requires approval by the Ethics Committee and trial patients made aware of new
information and reconsented using the new documentation.

3.2Obtaining Informed Consent

In obtaining
and documenting informed consent, the investigator should comply with any applicable
regulatory requirements, and should adhere to GCP and the Declaration of
Helsinki.

Informed
consent must be obtained from the trial subject (or legally acceptable
representative) before any trial related procedures are carried out.

Before informed
consent is obtained the subject should be allowed ample time and opportunity to
read the patient information sheet, to enquire about details of the trial and
to decide whether or not to participate.

If the
subject wishes to participate the written informed consent form should be
completed as appropriate and then signed and personally dated by the subject
and the investigator who conducted the informed consent discussions. Witness
signature is only required under ICH-GCP if the subject (or legally acceptable
representative) is unable to read. However it is still required by some ethic
committees and sponsor companies, in which case the investigator must comply
with their requirements. A copy of the signed and dated written informed
consent and any other written information must be provided to the subject prior
to participation in the trial. Similarily the subject should also receive
copies of any consent form updates or new information during the trial.

When atrial
involves subjects who can only be enrolled with the consent of their legally
acceptable representative (e.g. children), the subject should still be informed
about the trial to the extent compatible with their understanding and if
capable should also sign and date the consent form.

3.3 Storage of informed consent documents

A clean (blank) copy of the informed consent form
and information provided to the subjects that have been approved by the ethics
committee should be filed in the investigator site file.

All original
signed and dated consent forms should be filed at site. During the trial these
can be maintained appropriate Case record Forms. After the trial they can be
filed the patientís notes, CRF or in the investigator site file as appropriate.

It is the
responsibility of the sponsor company to inform the investigator when they can
destroy these documents.

3.4† Verification
of informed consent

The signed and dated written informed consent forms
must be available for review by the sponsor company representatives for data
verification purposes or audit. They must also be made available to any
regulatory body during regulatory inspection/audit visits.